CASE-CONTROL STUDY OF HEMIFACIAL MICROSOMIA AND DRUG USE

半面畸形与药物使用的病例对照研究

• 批准号: 6327381
• 负责人: MARTHA M. WERLER
• 金额: $ 45.66万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6327381
• 关键词: alcoholic beverage consumption; aspirin; caffeine; clinical research; coffee; congenital oral /facial /cranial defect; disease /disorder etiology; disease /disorder proneness /risk; embryo /fetus toxicology; epidemiology; gene environment interaction; human subject; ibuprofen; infant human (0-1 year); interview; maternal behavior; medical records; mother /embryo /fetus nutrition; nasal decongestants; nutrition related tag; questionnaires; smoking; telecommunications; tobacco abuse; vasoactive agent

DESCRIPTION: Hemifacial microsomia (HFM), the second most common craniofacial malformation, has significant functional and cosmetic consequences. While experimental evidence suggests a vascular etiology, there have been no published epidemiologic studies of risk factors for HFM, and its causes remain largely unknown. The proposed project is a continuation of a multicenter case-control study of HFM in relation to 1) maternal exposure to decongestants; 2) maternal exposure to other vasoactive agents, such as alcohol, coffee, cigarette smoking, aspirin, and ibuprofen; 3) maternal exposure to other environmental risk factors, such as other medications, illnesses, and nutritional factors; and 4) possible gene/environment interactions. We propose an additional aim: 5) to examine HFM risk in relation to the combination of decongestant and cigarette use. Cases will be identified at tertiary care institutions in 26 metropolitan areas in the U.S. and Canada. Controls will be identified by the case infant's primary physician (pediatrician or family doctor) and will comprise the next three infants born after the case. Mothers of cases and controls will be interviewed within three months after the date of case ascertainment by telephone. The standardized questionnaire inquires in detail about demographic factors; reproductive, medical and pregnancy illness histories; medication use; behaviors (smoking, alcohol, coffee); and nutrition. Before the interview, each mother will be sent a medication identification booklet which includes color pictures of over 200 over-the-counter cough/cold and analgesic products to help recall of medications used during early pregnancy. A separate component of the study will be collection of buccal cell samples from the study infant, and his/her mother and father. Standardized photographs will be taken and the medical record of each case infant will be reviewed for HFM classification. The original study expected to include 275 cases and 825 controls (3 controls per case) within 38 months of data collection. Ascertainment of cases has been lower than originally projected, with 77 percent of 275 (or 213) cases to be included by the end of data collection phase of the study. Continuation of the project for an additional 18 months will allow an additional 63 cases and 228 controls to be included. Thus, the original target number of cases and controls will be met.

描述：半面矮小症（HFM），第二常见的颅面畸形， 畸形，具有显著的功能和美容后果。而 实验证据表明是血管病因，目前还没有 已发表的HFM危险因素的流行病学研究，其原因仍然存在 大部分未知。 该项目是一项多中心病例对照研究的延续， HFM与1）母体接触减充血剂; 2）母体接触 其他血管活性剂，如酒精，咖啡，吸烟， 阿司匹林和布洛芬; 3）母亲暴露于其他环境风险 因素，如其他药物、疾病和营养因素;以及4） 基因与环境的相互作用我们提出了一个额外的目标：5） 检查减充血剂和香烟联合使用的HFM风险 使用. 将在26个大都市地区的三级保健机构确定病例 在美国和加拿大。对照组将通过病例婴儿的 初级医生（儿科医生或家庭医生），并将包括下一个 三个婴儿出生后的情况。病例和对照组的母亲将 在案件确定之日起三个月内， 电话.标准化问卷详细询问了人口统计学 因素;生殖、医疗和妊娠疾病史;药物使用; 行为（吸烟，饮酒，咖啡）;和营养。面试前，每 母亲将收到一本药物识别手册，其中包括颜色 超过200种咳嗽/感冒和止痛产品的图片，以帮助 在怀孕早期使用的药物。的单独部件 研究将采集研究婴儿的口腔细胞样本，以及 他的母亲和父亲。将拍摄标准化照片， 每例婴儿的医疗记录将被审查为HFM分类。 最初的研究预计包括275例病例和825例对照（3例对照 在数据收集的38个月内。案件的确定已经 低于最初的预测，275例（或213例）中的77%将被 在研究的数据收集阶段结束时纳入。继续 如果项目再延长18个月，将允许增加63个案件和228个案件。 应包括的控制。因此，病例和对照的最初目标数量 会得到满足。